欧洲医疗器械分类指导方针.docx

欧洲医疗器械分类指导方针.docx

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欧洲医疗器械分类指导方针

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4.2GENERALEXPLANATIONOFRULES/PRACTICALISSUES/EXAMPLES

规则、实际问题、举例简介

Rule1-Devicesthateitherdonottouchthepatientorcontactintactskinonly

规则1-不与病人接触或仅仅接触皮肤的器械

Generalexplanationoftherule

规则简介

Thisisafallbackruleapplyingtoalldevicesthatarenotcoveredbyamorespecificrule.

Thisisarulethatappliesingeneraltodevicesthatcomeintocontactonlywithintactskinorthatdonottouchthepatient.

这是一条适用于不被更高规则涵盖的器械的灵活规则

这是一条适用于主要是用于仅仅与完整皮肤接触或不与病人接触的器械的规则

RULE1

EXAMPLES

Allnon-invasivedevicesareinClassI,unless

oneoftherulessetouthereinafterapplies.

所有非侵入式器械均属于Ⅰ类：

除非下列规则之一适用。

-Bodyliquidcollectiondevicesintendedtobeusedinsuchawaythatareturnflowisunlikely（e.g.tocollectbodywastessuchasurinecollectionbottles,ostomypouches,incontinencepadsorcollectorsusedwithwounddrainagedevices）.Theymaybeconnectedtothepatientbymeansofcathetersandtubing.

-体液（此体液不可能回流）收集器械（如尿液收集瓶、造瘘袋、失禁垫或伤口引流收集器），此类器械一般通过管子或输尿管与病人身体相连。

-Devicesusedtoimmobilizebodypartsand/ortoapplyforceorcompressiononthem

（e.g.non-steriledressingsusedtoaidthehealingofasprain,plasterofParis,cervicalcollars,gravitytractiondevices,compressionhosiery）.

-局部制动和/或加压的器械（如扭伤康复的未消毒敷料、石膏、颈托、重力牵引器、弹性袜）

-Devicesintendedingeneralforexternalpatientsupport（e.g.hospitalbeds,patienthoists,walkingaids,wheelchairs,stretchers,dentalpatientchairs）.

-Correctiveglasses,frames,stethoscopesfordiagnosis,eyeocclusionplasters,incision

drapes,conductivegels,non-invasiveelectrodes（electrodesforEEGorECG）,image

intensifyingscreens.

主要用于体外支持的器械（如医用床、拐杖、轮椅、担架、牙科椅）

-矫形眼镜、矫形架、诊断用听诊器、眼科石膏、胶带、导电凝胶、非侵入式电极（ECGEKG电极）、显示屏

-Permanentmagnetsforremovalofoculardebris

-祛除眼碎屑的永久性磁铁

Practicalissuesofclassification

分类的实际问题

Somenon-invasivedevicesareindirectlyincontactwiththebodyandcaninfluenceinternalphysiologicalprocessesbystoring,channelingortreatingblood,otherbodyliquidsorliquidswhicharereturnedorinfusedintothebodyorbygeneratingenergythatisdeliveredtothebody.Thesemustbeexcludedfromtheapplicationofthisruleandbehandledbyanotherrulebecauseofthehazardsinherentinsuchindirectinfluenceonthebody.

一些非侵入性器械不与身体直接接触但可以影响生理过程（通过血液、其他体液或重新吸收或注入体内的液体的转化、引流、处理或者输入体内的能量转换的方式来实现）。

这些器械不适用于以上规则，因为他们本身对身体有潜在的危害

Rule2-Channelingorstoringforeventualadministration

规则2最终用于药控的导引或存储

Generalexplanationoftherule

规则简述

Thesetypesofdevicesmustbeconsideredseparatelyfromthenon-contactdevicesofrule1becausetheymaybeindirectlyinvasive.Theychannelorstoresubstancesthatwillbeeventuallydeliveredintothebody.Typicallythesedevicesareusedintransfusion,infusion,extracorporealcirculation,deliveryofanaestheticgasesandoxygen.

这类器械应与规则1所述的非接触性器械分开来因为他们可能不直接侵入。

他们引导或存储那些最终会注入人体的物质，典型产品：

用于转运，注射，体外循环，投递麻醉气体或的器械。

Insomecasesdevicescoveredunderthisruleareverysimplegravityactivateddeliverydevices.

有些情况下，这条规则所属的器械仅仅是重力源性投递器械

RULE2

EXAMPLES

Allnon-invasivedevicesintendedforchannelingorstoringblood,bodyliquidsortissues,liquidsorgasesforthepurposeofeventualinfusion,administrationorintroductionintothebodyareinClassIIa:

-iftheymaybeconnected1toanactivemedicaldeviceinClassIIaorahigherclass,用于引导或储存血液、体液或人体或人体组织、液体或气体供最终注入、施入或导入人体的所有非侵入性器械。

如果他们可以连接Ⅱ类或更高级别的有源医疗器械则其属于Ⅱa类

-Devicesintendedtobeusedaschannelsinactivedrugdeliverysystems,e.g.tubingintendedforusewithaninfusionpump.-Devicesusedforchanneling,e.g.antistatictubingforanesthesia,anesthesiabreathingcircuitsandpressureindicator,pressurelimitingdevices.-Syringesforinfusionpumps.

-有源药物投递通道器械如（与灌输泵连用的管子）

-导入器械如（抗静电麻醉管麻醉呼吸循环与压力指示器压力限制器）

-灌注用耳咽管

-iftheyareintendedforuseforstoringorchannellingbloodorotherbodyliquidsorforstoringorgans,partsoforgansorbodytissues（areinClassIIa）

如果用于储存和导引血液或其他体液或组织则其属于Ⅱa类

-Devicesintendedtochannelblood（e.g.intransfusion,extracorporealcirculation）.-Devicesintendedfortemporarystorageandtransportoforgansfortransplantation.-Devicesintendedforlongtermstorageofbiologicalsubstancesandtissuessuchascorneas,sperm,humanembryos,etc.

-用于提供血液引流通道作用的器械如（输血、体外循环）

-临时储存生物物质和组织如（角膜、精子、人胚等器械）

inallothercasestheyareinClassI.

其他情况下属于Ⅰ类

-Devicesthatprovideasimplechannelingfunction,withgravityprovidingtheforcetotransporttheliquid,e.g.administrationsetsforinfusion.-Devicesintendedtobeusedforatemporarycontainmentorstoragefunctionsuchascupsandspoonsspecificallyintendedforadministeringmedicines2.-Syringeswithoutneedles

-仅仅是利用重力来导引液体如（注射滴瓶）

-暂时包裹或储存用的器械如（管制药物杯、勺）

-无针耳咽管

Practicalissuesofclassification

分类的实际问题

Bloodbagsarecoveredasanexceptionunderaseparaterule（seerule18）.

血袋是例外（参见规则18）

Ifadevice,e.g.tubing,canbeusedforapurposethatwouldcauseittobeconnectedtoanactivedevicesuchadevicewillbeautomaticallyinClassIIA,unlessthemanufacturerclearlystatethatitshouldnotbeconnectedtoanactivedeviceofClassIIAorhigher.

如果一种器械比如管子与有源器械相连而发挥作用，则这种器械自动归于Ⅱa类，除非制造商明确规定其不与Ⅱa类或者更高级别的器械连用。

Explanationofspecialconcepts

专业术语解释

Note1:

"Maybeconnectedtoanactivedevice".Suchconnectionisdeemedtoexistbetweenanon-activedeviceandanactivedevicewhereanon-activedeviceformsalinkinthetransferofthesubstancebetweenthepatientandtheactivedeviceandthesafetyandperformanceofoneofthedevicesisinfluencedbytheotherdevice.Forinstance,thisappliestotubinginanextracorporealcirculationsystemwhichisdownstreamfromabloodpumpandinthesamebloodflowcircuit,butnotdirectlyincontactwiththepump.

“与有源器械相连”指的是这种器械存在与无源和有源器械之间，而无源器械起到连接病人和有源器械物质转运的纽带作用且他们之间的安全性和性能互相影响制约。

比如，存在于血泵下游和血流循环之间但并不和血泵直接相连的体外循环系统的管子。

Note2:

Solutionsintendedforpreservationoforgansduringstorageandtransportarenotmedicaldevices.

用于储存和移植期间保护器官的溶液不属于医疗器械

Rule3-Devicesthatmodifybiologicalorchemicalcompositionofblood,bodyliquidsorotherliquids

规则3-用于改变血液、体液或其他液体的生物或化学组分的器械

Generalexplanationoftherule

规则简介

Thesetypesofdevicesmustbeconsideredseparatelyfromthenon-contactdevicesofrule1becausetheyareindirectlyinvasive.Theytreatormodifysubstancesthatwillbeeventuallydeliveredintothebody.Thisrulecoversmostlythemoresophisticatedelementsofextracorporealcirculationsets,dialysissystemsandautotransfusionsystemsaswellasdevicesforextracorporealtreatmentofbodyfluidswhichmayormaynotbereintroducedimmediatelyintothebody,including,wherethepatientisnotinaclosedloopwiththedevice..

这类器械应与规则1所述的非接触性器械分开来因为他们不直接侵入人体。

他们处理或改变那些最终会注入人体的物质。

这条规则涵盖了大多数的更专业化的体外循环元件、透析系统、自体循环系统以及那些可能或者可能不立即注入进人体的体外体液处理设备，包括那些使病人不处于这些封闭式循环器械之内的器械。

RULE3

EXAMPLES

Allnon-invasivedevicesintendedformodifyingthebiologicalorchemicalcompositionofblood,otherbodyliquidsorotherliquidsintendedforinfusionintothebodyareinClassIIb,

用于改变注入人体的血液、其他体液或其他体液的生物和化学成分的所有非侵入性器械归于Ⅱb类

-Devicesintendedtoremoveundesirablesubstancesoutofthebloodbyexchangeofsolutessuchashemodyalizers

-Devicesintendedtoseparatecellsbyphysicalmeans,e.g.gradientmediumforspermseparation.

-Haemodialysisconcentrates.

-用于通过溶质加换达到去除血液中的有害物质目的的器械，如hemodyalizers

-用物理方法分离细胞的器械，如精液分离媒

-血析浓缩机

unlessthetreatmentconsistsoffiltration,centrifugationorexchangeofgasorheat,inwhichcasetheyareinClassIIa.

若治疗过程包括过滤、离心、或气热交换，则其归属与Ⅱa类

-Particulatefiltrationofbloodinanextracorporealcirculationsystem.Theseareusedtoremoveparticlesandembolifromtheblood.

-Centrifugationofbloodtoprepareitfortransfusionorautotransfusion.-Removalofcarbondioxidefromthebloodand/oraddingoxygen.

-Warmingorcoolingthebloodinanextracorporealcirculationsystem.

-体外循环系统特制筛网，用于筛掉血中的小微粒和杂质

-血液离心机血中去除CO2或增加O2

-体外血液循环系统制冷制热

Practicalissuesofclassification

分类的实际应用

Thesedevicesarenormallyusedinconjunctionwithanactivemedicaldevicecoveredunderrule9orrule11.

这些器械通常是连接与规则9或11类的有源医疗器械

Filtrationandcentrifugationshouldbeunderstoodinthecontextofthisruleasexclusivelymechanicalmethods.

过滤和离心在这条中应被理解为单一的机械方法

Rule4-Devicesincontactwithinjuredskin

与受伤皮肤接触的器械

Generalexplanationoftherule

规则简介

Thisruleisintendedtocoverprimarilywounddressingsindependentlyofthedepthofthewound.Thetraditionaltypesofproducts（e.g.usedasamechanicalbarrier）arewellunderstoodanddonotresultinanygreathazard.Therehavealsobeenrapidtechnologicaldevelopmentsinthisarea,withtheemergenceofnewtypesofwounddressingsforwhichnon-traditionalclaimsaremade,e.g.managementofthemicro-environmentofawoundtoenhanceitsnaturalhealingmechanism.Moreambitiousclaimsrelatetothemechanismofhealingbysecondaryintent,suchasinfluencingtheunderlyingmechanismsofgranulationorepithelialformationorpreventingcontractionofthewound.Somedevicesusedonbreacheddermismayevenhavealife-sustainingorlife-savingpurpose,e.g.whenthereisfullthicknessdestructionoftheskinoveralargeareaand/orsystemiceffect.DressingscontainingmedicinalproductsactingasancillarytothedressingfallwithinClassIIIunderRule13.

这条规则主要适用于那些主要是用于独立作用于伤口深度的伤口敷料，传统的产品种类如：

用作机械屏障，很容易让人明白而且不产生任何危险。

这个领域技术发展迅速，出现了许多非传统的伤口敷料，如可控制伤口微环境以有利于伤口恢复的敷料。

也出现了许多对二次恢复有效的敷料，如影响肉芽生长、上皮重建、防止伤口收缩用的伤口敷料。

有的用于伤及真皮的敷料可以挽救、支持生命，如大面积全程毁坏或系统性影响。

含有药物成分的敷料起到辅助作用按照规则13则归属于三类

RULE4

EXAMPLES

Allnon-invasivedeviceswhichcomeintocontactwithinjuredskin:

-areinClassIiftheyareintendedtobe